BEN VENUE LABORATORIES, INC.

About BEN VENUE LABORATORIES, INC.

Ben Venue Laboratories puts liquid medications on the menu. A subsidiary of German drug firm Boehringer Ingelheim, the company provides contract manufacturing services, including process development and regulatory compliance services, from its production facilities in Bedford, Ohio. Ben Venue specializes in manufacturing liquid and lyophilized (freeze-dried) pharmaceuticals, with its Bedford Laboratories division making generic injectable pharmaceuticals on both a proprietary and contract basis. Its worldwide customers include multinational drugmakers, small biotech development firms, and government agencies. However, quality issues have prompted Ben Venue to suspend its manufacturing operations.

Despite efforts to expand its contract development and manufacturing operations, in mid-2011 Ben Venue faced quality lapses and capacity constraints that curtailed its ability to meet customer demand and created shortages of critical cancer drugs (including Johnson & Johnson's popular Doxil medication). After Canadian and European regulators found quality problems and banned the importing of some its drugs, Ben Venue announced it would exit the contract manufacturing business over several years.

The company planned to instead focus on the proprietary operations of its Bedford Laboratories division, which conducts internal R&D efforts and manufactures generic sterile pharmaceuticals including anesthetic, cardiovascular, and oncology drugs. However, in late 2011 Ben Venue suspended all manufacturing operations after an internal review revealed that preventative maintenance and equipment testing at the facility was behind schedule. The shutdown has escalated the already severe shortage of certain cancer drugs in the US market.

The FDA has reported procedural problems at the facility as well, and following the shutdown, the European Medicines Agency (EMA) issued recalls of several contract products made by Ben Venue, including Pfizer's antifungal drug Ecalta, Bristol-Myers Squibb's diagnostic agent Luminity, and Gilead Sciences anti-infective Vistide. It also recalled three cancer medicines (Busilvex, Velcade, and Vidaza, which are made on a contract basis for drugmakers Pierre Fabre, J&J, and Celgene) that have available alternatives on the European market, and advised doctors to inspect critical oncology drugs Ceplene (marketed by Meda) and Torisel (sold by Pfizer) for foreign particles before administering the drugs.

In 2014 the company sold its remaining manufacturing business, Bedford Labs, which makes injectable generics, to Hikma. The buyer gained a product portfolio, intellectual property, contracts, and the R&D pipeline. Later it also purchased the manufacturing facility.